BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2923462 · Received January 22, 2013

    Report

    Report Number
    3004493922-2013-00147
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 18, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE TERRITORY BUSINESS MANAGER THAT THE M51PSR20B POWER WHEELCHAIR WAS SPEEDING AND SLOWING DOWN WITHOUT COMMAND. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30947 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51PSR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other